KnowHow: The FDB Blog

FDA's Biosimilar ID Requirements Fly in the Face of Cost-Cutting Aspirations

Corporate Perspective, Government, Standards
Friday, November 10, 2017 by Tom Bizzaro, RPh

Curiously, the FDA seems to be undercutting its own cost savings efforts through its support of a rule that would require unique non-proprietary names with four-character suffixes for biosimilar products. The problem is this proposed naming convention is simply not necessary and could do more harm than good. Read more...

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Questionable Direction

FDA Direction on Biosimilar Naming Poses More Questions Than Answers

Corporate Perspective, FDA, Government, Standards
Thursday, September 10, 2015 by Tom Bizzaro, RPh & Patrick Lupinetti, JD

On August 27, the Food & Drug Administration (FDA) released draft guidance and a proposed rule on the naming of biologic drugs and biosimilars. Although in agreement in their opposition to the FDA action, FDB’s Tom Bizzaro and Patrick Lupinetti share two perspectives on this controversial issue. Read more...

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Interoperability Blog Picture

EHR Interoperability Following in E-Prescribing's Footsteps?

Corporate Perspective, Standards, Government
Wednesday, December 10, 2014 by Tom Bizzaro, RPh

The current EHR interoperability movement could take a page or two out of the e-prescribing book. Read more...

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Pill Bottles

2014 Update: Demystifying Source NDC Codes, Repackaged Products and Biosimilars

Corporate Perspective, FDA, Standards
Thursday, October 23, 2014 by Julie Suko, PharmD

It’s time for the 2014 update to what the FDB marketing department informs me on a regular basis is the most popular FDB blog topic of all time. Read more...

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I Heart HIT Avatar

Moving Toward EHR Interoperability is Something to Be Happy About

Corporate Perspective, Transformational Change, Government, Standards
Friday, September 12, 2014 by Tom Bizzaro, RPh

It’s National Health IT Week once again which has prompted me to start thinking about how far IT has come and how far it needs to go in healthcare. Read more...

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